Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes

Obesity Clinical Trial

Official title:

The Efficacy of a Transcultural Diabetes Nutrition Algorithm (tDNA) Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes in an Outpatient Clinic Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881540
• Other study ID #: IMU R 134/2014
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2019
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counselling technique in an outpatient clinic setting.

The hypothesis is weight loss and glycated haemoglobin (A1C) level will be improved in patients following the tDNA care compared to usual diabetes care and the improvements will be greater in those receiving motivational interviewing counseling than conventional counselling.

Description:

The main objective of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counseling technique in an outpatient clinic setting.

The specific objectives are:

1. To compare changes in the primary outcomes (weight, body mass index and A1C) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention.

2. To compare changes in the secondary outcomes (waist circumference, percentage body fat, fasting plasma glucose, lipid profile, high sensitivity-C-Reactive Protein and blood pressure) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, and 6 months of intervention.

3. To compare the changes in dietary intake, Weight Efficacy Lifestyle, exercise and physical activity in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention.

Study Design: This is a prospective open-label randomized clinical trial conducted in patients with overweight, obesity and T2D in an outpatient clinic setting.

Study duration: This study was conducted for a period of 12 months consisting of 6 months of intervention phase followed by subsequent 6 months of follow up phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus, requiring weight loss

2. Treated with oral hypoglycaemic medications and/or lifestyle modifications

3. Medications have been optimised with no changes in pharmacotherapy in the past three months

4. Aged between 30 to 65 years

5. BMI of >23 kg/m²

6. A1C between 7% to 9%

7. Failed to achieve HbA1c reduction in the past three months even after seeing a dietitian

8. Willing to comply with study procedures.

Exclusion Criteria:

1. Patients whom weight loss might not be safe

2. Patients diagnosed with type 1 diabetes mellitus and type 2 diabetes mellitus with basal or multiple insulin injections

3. Patients with weight loss exceeding 5 kg in the past three months

4. Patients with current use of medications/meal replacements for weight loss

5. Patients with cancer requiring treatment for the past five years, except of non-melanoma skin cancers or cancers that have been clearly cured

6. Patients with history of bariatric surgery, small bowel resection, or extensive bowel resection

7. Patients with cardiovascular disease (heart attack or procedure within past three months or participation in cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischaemic attacks in the past three months, or documented history of pulmonary embolus for the past six months)

8. Patients receiving chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion.

9. Patients with renal disease with eGFR <60 ml/min (based on MDRD) or currently receiving dialysis

10. Patients with chronic alcoholism

11. Patients who are currently pregnant or nursing

12. Patients who plan to relocate where it does not permit full participation in the study.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Obesity
• Overweight
• Weight Loss

Intervention

Other:
• tDNA-MI group
tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements and motivational interviewing counseling. .
• tDNA-CC group
tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements+ 150 min/week of moderate intensity exercise + and conventional counselling.
• UC group
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling

Locations

Country	Name	City	State
Malaysia	International Medical University	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
International Medical University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Anthropometry	6 months, 12 months
Primary	Change in Glycated haemoglobin (A1C)	Biochemical measure	6 months, 12 months
Secondary	Change in percentage body fat	Body composition	6 months
Secondary	Change in fasting blood glucose	Biochemical measure	6 months
Secondary	Change in total cholesterol, LDL-C and HDL-C	Biochemical measure	6 months
Secondary	Change in High sensitivity C-Reactive Protein (HsCRP)	Biochemical measure	6 months
Secondary	Change in systolic and diastolic blood pressure	Metabolic outcome	6 months
Secondary	Change in energy intake and macronutrients	Dietary intake	6 months, 12 months
Secondary	Change in Weight Efficacy Lifestyle (WEL) scores	Eating self efficacy scores ranging from total scores of 0-180, subscales of 0-36. Total scores is a sum of subscales. Higher scores are better.	6 months, 12 months
Secondary	Change in exercise minutes	Exercise	6 months, 12 months